ObesityNCT03555110
Effects of EMDR Therapy in Patients With Severe Obesity
A study testing Personality Factor Battery Test (PFB Test) and Eye Movement Desensitization and Reprocessing Therapy (EMDR) in people with Obesity and Emotional Trauma, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The aims of the study are to perform psychological intervention using EMDR Therapy (Eye Movement Desensitization and Reprocessing Therapy) in the preoperative period, evaluate the personality of each patient through the PFB test (Personality Factor Battery Test) at different times, compare the results obtained in the… Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Obesity, Emotional Trauma
- What is being tested?
- Personality Factor Battery Test (PFB Test) and Eye Movement Desensitization and Reprocessing Therapy (EMDR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2018to 2 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- both sexes
- BMI between 40 Kg/m2 and 50 Kg/m2
- ages between 30 and 55 years,
- minimum level of Elementary School, previously evaluated psychologically by the Psychology Service - University of São Paulo Medical School
Who cannot join
- history of severe personality disorders: psychotic symptoms or schizophrenia; bipolar disorder or dementia - groups A and B (DSM - IV);
- patients who present severe dissociative disorders (score above 25%), evaluated through the Dissociative Experiences Scale (DES);
- patients with heart problems and current pregnancy, with information obtained through the participants' reports.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, 05403900
Roberto de Cleva, 55 11 999774502, roberto.cleva@hc.fm.usp.br
Vivian Stipp, 55 11 986206060, vivistipp@hotmail.com
About this study
Official title: Effects of EMDR Therapy in Patients With Severe Obesity Submitted to Bariatric Surgery
The aims of the study are to perform psychological intervention using EMDR Therapy (Eye Movement Desensitization and Reprocessing Therapy) in the preoperative period, evaluate the personality of each patient through the PFB test (Personality Factor Battery Test) at different times, compare the results obtained in the PFB test at different times of application and verify the existence of changes in the five major Personality Factors: Neuroticism, Extroversion, Socialization, Realization and Openness.
Read the detailed description
Obesity is a multi-factorial disease requiring a multi-professional approach. Psychological causes also contribute to the development and maintenance of obesity. Traumatic experiences may be a risk factor for it as well. Emotional issues of obese patient often interfere with the results of bariatric surgery, where a large number of bariatric patients regain the weight or change symptoms.
The aim of the Effects of EMDR therapy with Severe Obesity Bariatric Surgery Patients randomized controlled trial is to determine the effects of 11 sessions of EMDR therapy, prior to surgery as compared to a control group. The Big Five personality factors will be used to evaluate the results. Both groups of patients will complete the Factorial Personality Battery, before the surgery, and 6 months and 12 months following bariatric surgery.
The initial hypothesis is that EMDR therapy will provide sufficient changes after surgery in the personality dynamics of obese patients, which will in turn favor emotional balance and weight maintenance as compared to the control group.
- Conditions
- Obesity, Emotional Trauma
- Being tested
- Personality Factor Battery Test (PFB Test), Eye Movement Desensitization and Reprocessing Therapy (EMDR)
- Keywords
- EMDR Therapy, Bariatric Surgery, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personality Factor Battery Test (PFB Test)Behavioural
Psychological instrument built for personality evaluation from the model of the Five Great Factors (FGF), that includes the following dimensions: Neuroticism, Extroversion, Socialization, Effort / Commitment), focusing on the component of the aspects of Neuroticism.
Eye Movement Desensitization and Reprocessing Therapy (EMDR)Behavioural
It is a psychotherapeutic approach effective on treatment for trauma and post-traumatic stress disorder. It is an intervention that allows the desensitization of negative emotions from traumatic experiences.This therapy modifies memories that have been processed non-adaptively and become painful and dysfunctional memories. During the procedure, the patient is encouraged to move the eyes from side to side, associating these movements with a "target" situation, previously defined at the beginning of the session. The ocular movements can be replaced by tactile or sonorous stimuli. The series of stimuli must continue until the memory of the traumatic event can be reprocessed adaptively, that is, without the emotional, negative or painful process associated with that memory.
| Study group | Role | What they receive |
|---|---|---|
| Controlled Group | Active comparator | 30 morbid obese patients, 30 to 55 years old, submitted to Personality Factor Battery Test (PFB Test) during the study with the same frequency and criteria of the group of EMDR . Receives: Behavioral: Personality Factor Battery Test (PFB Test) |
| EMDR Group | Active comparator | 30 morbid obese patients, 30 to 55 years old, submitted to Eye Movement Desensitization and Reprocessing Therapy (EMDR) during the study with the frequency of Twelve sessions, including:
* Three evaluation and preparation sessions,
* Eight EMDR sessions weekly with variable length of 60 minutes and
* One closing session. The total intervention time will be about 3 (three) months. After the end of the 12 sessions of EMDR therapy, the patient will be evaluated again individually to verify the existence of change in PFB test results about the 5 big factors. The instrument will also be reapplied three months, twelve months and thirty-six months after bariatric surgery. Receives: Behavioral: Eye Movement Desensitization and Reprocessing Therapy (EMDR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in emotional balance
This will be evaluated by the Factorial Personality Battery before and after surgery
Measured: Postoperative (3 months, 12 months and 36 months after bariatric surgery)
Secondary outcomes (1)
Total Weight loss
weight loss measured in percentage of weight loss (%WL)
Measured: Postoperative (3 months, 12 months and 36 months after bariatric surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start1 Feb 2018
- Primary completion2 Jun 2018
- Study completion2 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto de Cleva, University of Sao Paulo
- Investigators
- Roberto De Cleva, Principal investigator, Hospital das Clinicas da Faculdade de Medicina da USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555110
- Sponsor's protocol ID
- 78695317.3.0000.0068
- Status last verified
- Oct 2019
- First submitted
- 9 May 2018
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan is to publish the complete data after the end of the study
Publications
Alvarez J, Pavao J, Baumrind N, Kimerling R. The relationship between child abuse and adult obesity among california women. Am J Prev Med. 2007 Jul;33(1):28-33. doi: 10.1016/j.amepre.2007.02.036.
PubMed 17572308Cordas TA, Lopes Filho AP, Segal A. [Eating disorder and bariatric surgery: a case report]. Arq Bras Endocrinol Metabol. 2004 Aug;48(4):564-71. doi: 10.1590/s0004-27302004000400019. Epub 2005 Mar 7. Portuguese.
PubMed 15761522Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
PubMed 9635069Perkonigg A, Owashi T, Stein MB, Kirschbaum C, Wittchen H-U. Posttraumatic stress disorder and obesity: evidence for a risk association. Am J Prev Med. 2009 Jan;36(1):1-8. doi: 10.1016/j.amepre.2008.09.026. Epub 2008 Oct 31.
PubMed 18976880Shapiro, F. Dessensibilização e Reprocessamento Através de Movimentos Oculares: Princípios Básicos, Protocolos e Procedimentos. (2a. ed.) - Brasília: Nova Temática, 2007
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of EMDR Therapy in Patients With Severe Obesity Submitted to Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03555110
- Acronym / sponsor ID
- 78695317.3.0000.0068
- Conditions
- Obesity, Emotional Trauma
- Keywords
- EMDR Therapy, Bariatric Surgery, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 2 Jun 2018 (actual)
- Study completion
- 2 Jun 2020 (estimated)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of the study are to perform psychological intervention using EMDR Therapy (Eye Movement Desensitization and Reprocessing Therapy) in the preoperative period, evaluate the personality of each patient through the PFB test (Personality Factor Battery Test) at different times, compare the results obtained in the PFB test at different times of application and verify the existence of changes in the five major Personality Factors: Neuroticism, Extroversion, Socialization, Realization and Openness.
Detailed description
Obesity is a multi-factorial disease requiring a multi-professional approach. Psychological causes also contribute to the development and maintenance of obesity. Traumatic experiences may be a risk factor for it as well. Emotional issues of obese patient often interfere with the results of bariatric surgery, where a large number of bariatric patients regain the weight or change symptoms.
The aim of the Effects of EMDR therapy with Severe Obesity Bariatric Surgery Patients randomized controlled trial is to determine the effects of 11 sessions of EMDR therapy, prior to surgery as compared to a control group. The Big Five personality factors will be used to evaluate the results. Both groups of patients will complete the Factorial Personality Battery, before the surgery, and 6 months and 12 months following bariatric surgery.
The initial hypothesis is that EMDR therapy will provide sufficient changes after surgery in the personality dynamics of obese patients, which will in turn favor emotional balance and weight maintenance as compared to the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Controlled Group | Active comparator | Behavioral: Personality Factor Battery Test (PFB Test)30 morbid obese patients, 30 to 55 years old, submitted to Personality Factor Battery Test (PFB Test) during the study with the same frequency and criteria of the group of EMDR . |
| EMDR Group | Active comparator | Behavioral: Eye Movement Desensitization and Reprocessing Therapy (EMDR)30 morbid obese patients, 30 to 55 years old, submitted to Eye Movement Desensitization and Reprocessing Therapy (EMDR) during the study with the frequency of Twelve sessions, including: * Three evaluation and preparation sessions, * Eight EMDR sessions weekly with variable length of 60 minutes and * One closing session. The total intervention time will be about 3 (three) months. After the end of the 12 sessions of EMDR therapy, the patient will be evaluated again individually to verify the existence of change in PFB test results about the 5 big factors. The instrument will also be reapplied three months, twelve months and thirty-six months after bariatric surgery. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- both sexes
- BMI between 40 Kg/m2 and 50 Kg/m2
- ages between 30 and 55 years,
- minimum level of Elementary School, previously evaluated psychologically by the Psychology Service - University of São Paulo Medical School
Key exclusion criteria (3 listed)
- history of severe personality disorders: psychotic symptoms or schizophrenia; bipolar disorder or dementia - groups A and B (DSM - IV);
- patients who present severe dissociative disorders (score above 25%), evaluated through the Dissociative Experiences Scale (DES);
- patients with heart problems and current pregnancy, with information obtained through the participants' reports.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personality Factor Battery Test (PFB Test)Psychological instrument built for personality evaluation from the model of the Five Great Factors (FGF), that includes the following dimensions: Neuroticism, Extroversion, Socialization, Effort / Commitment), focusing on the component of the aspects of Neuroticism. | Behavioural | Controlled Group |
| Eye Movement Desensitization and Reprocessing Therapy (EMDR)It is a psychotherapeutic approach effective on treatment for trauma and post-traumatic stress disorder. It is an intervention that allows the desensitization of negative emotions from traumatic experiences.This therapy modifies memories that have been processed non-adaptively and become painful and dysfunctional memories. During the procedure, the patient is encouraged to move the eyes from side to side, associating these movements with a "target" situation, previously defined at the beginning of the session. The ocular movements can be replaced by tactile or sonorous stimuli. The series of stimuli must continue until the memory of the traumatic event can be reprocessed adaptively, that is, without the emotional, negative or painful process associated with that memory. | Behavioural | EMDR Group |
Primary outcome
change in emotional balance
Time frame: Postoperative (3 months, 12 months and 36 months after bariatric surgery)
This will be evaluated by the Factorial Personality Battery before and after surgery
1 secondary outcome
Total Weight loss
Time frame: Postoperative (3 months, 12 months and 36 months after bariatric surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Background: PubMed 17572308Alvarez J, Pavao J, Baumrind N, Kimerling R. The relationship between child abuse and adult obesity among california women. Am J Prev Med. 2007 Jul;33(1):28-33. doi: 10.1016/j.amepre.2007.02.036.
- Background: PubMed 15761522Cordas TA, Lopes Filho AP, Segal A. [Eating disorder and bariatric surgery: a case report]. Arq Bras Endocrinol Metabol. 2004 Aug;48(4):564-71. doi: 10.1590/s0004-27302004000400019. Epub 2005 Mar 7. Portuguese.
- Background: PubMed 9635069Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
- Background: PubMed 18976880Perkonigg A, Owashi T, Stein MB, Kirschbaum C, Wittchen H-U. Posttraumatic stress disorder and obesity: evidence for a risk association. Am J Prev Med. 2009 Jan;36(1):1-8. doi: 10.1016/j.amepre.2008.09.026. Epub 2008 Oct 31.
- BackgroundShapiro, F. Dessensibilização e Reprocessamento Através de Movimentos Oculares: Princípios Básicos, Protocolos e Procedimentos. (2a. ed.) - Brasília: Nova Temática, 2007
- Individual participant dataSharing planned: No. The plan is to publish the complete data after the end of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto De Cleva principal investigator
Hospital das Clinicas da Faculdade de Medicina da USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personality Factor Battery Test (PFB Test) and Eye Movement Desensitization and Reprocessing Therapy (EMDR) in people with Obesity and Emotional Trauma, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto de Cleva (55 11 999774502, roberto.cleva@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in emotional balance (time frame: Postoperative (3 months, 12 months and 36 months after bariatric surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03555110, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.